Final Report on the Safety Assessment of Laneth-10 Acetate Group

1982 ◽  
Vol 1 (4) ◽  
pp. 1-24 ◽  
Keyword(s):  
Guinea Pig ◽  
Topical Application ◽  
Safety Assessment ◽  
Final Report ◽  
Acute Oral Toxicity ◽  
Cosmetic Products ◽  
Dermal Toxicity ◽  
Oral Toxicity ◽  
Toxicity Studies ◽  
Animal Data

The Laneths are ethoxylated lanolin alcohols that may be acetylated and used in a wide variety of cosmetic products. Acute oral toxicity studies indicate that Laneth-10 Acetate is relatively nontoxic to the rat; acute dermal toxicity studies indicate that it is relatively nontoxic to the guinea pig. Laneth-10 Acetate was found to be a mild, transient irritant to the rabbit's eye. Laneth-10 Acetate was shown to be nonirritating and nonsensitizing to SO subjects. Laneth-16 is slightly toxic when administered orally to the rat. Neither Laneth-16 nor Laneth-25 was a skin irritant or sensitizing agent in 50 subjects. On the basis of the available animal data and limited human experience presented in this report, it is concluded that the Laneths are safe for topical application to humans in the present practices of use and concentration.

5 Final Report on the Safety Assessment of Potassium-Coco-Hydrolyzed Animal Protein and Triethanolamine-Coco-Hydrolyzed Animal Protein

1983 ◽  
Vol 2 (7) ◽  
pp. 75-86 ◽  
Keyword(s):  
Guinea Pig ◽  
Safety Assessment ◽  
Condensation Product ◽  
Animal Protein ◽  
Final Report ◽  
Acute Oral Toxicity ◽  
Cosmetic Products ◽  
Oral Toxicity ◽  
Cosmetic Ingredients ◽  
Available Information

Potassium and TEA-Coco-Hydrolyzed Animal Proteins (PCHAP and TEA-CHAP) are salts of the condensation product of coconut acid and hydrolyzed animal protein. They are used in cosmetic products as detergents, foamers, and levelers. Acute oral toxicity studies showed that both PCHAP and TEA-CHAP were practically nontoxic when ingested. Both ingredients at concentrations of 10%-100% were practically nonirritating to moderately irritating when instilled in the eyes of rabbits. Both were nonirritating to mildly irritating when applied at concentrations of 10%-50% to the skin of rabbits. Guinea pig sensitization studies with both PCHAP and TEA-CHAP were negative. PCHAP and TEA-CHAP, at concentrations of 2% 10% were nonirritating to practically nonirritating in humans. In a repeated insult patch test, PCHAP gave a positive sensitization reaction in two of 168 subjects; two additional subjects showed cumulative irritation and one other was reported to have a nonspecific irritation. One subject out of 28 tested did not demonstrate significant irritation or sensitivity to either PCHAP or TEA-CHAP, but was photosensitized to both ingredients. On the basis of the available information, the Panel concludes that Potas-sium-Coco-Hydrolyzed Animal Protein and TEA-Coco-Hydrolyzed Animal Protein are safe as cosmetic ingredients in the present practices of use as recorded in this report.

Final Report on the Safety Assessment of Glycol Stearate, Glycol Stearate SE, and Glycol Distearate

1990 ◽  
Vol 1 (2) ◽  
pp. 1-11 ◽  
Keyword(s):  
Safety Assessment ◽  
Skin Irritation ◽  
Laboratory Animals ◽  
Final Report ◽  
Acute Oral Toxicity ◽  
Cosmetic Products ◽  
Oral Toxicity ◽  
Animal Data ◽  
Cosmetic Ingredients ◽  
Available Information

Glycol Stearate, Glycol Stearate SE, and Glycol Distearate consist primarily of the mono- and diesters of triple-pressed stearic acid. They are used in numerous categories of cosmetic products at concentrations ranging from less than 0.1 to 10%. Animal data for acute oral toxicity, skin and eye irritation, and sensitization show that these ingredients have low acute toxicity. A repeated insult patch test with 50% Glycol Distearate on 125 subjects presented no evidence of skin irritation or hypersensitivity. Human studies using formulations containing Glycol Stearate at levels of 2-5% reported no skin irritation or sensitization. Subchronic testing has not been adequately investigated in laboratory animals. Human test data for formulations containing > 4% Glycol Stearate or Glycol Distearate should be considered. Based on the available information presented herein, it is concluded that Glycol Stearate, Glycol Stearate SE, and Glycol Distearate are safe as cosmetic ingredients in the present practices of use and concentration.

Final Report of the Safety Assessment of Kojic Acid as Used in Cosmetics

2010 ◽  
Vol 29 (6_suppl) ◽  
pp. 244S-273S ◽  
Author(s):  
Christina L. Burnett ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Guinea Pig ◽  
Safety Assessment ◽  
Expert Panel ◽  
Kojic Acid ◽  
Tumor Promotion ◽  
Final Report ◽  
Cosmetic Products ◽  
Pig Skin ◽  
Animal Data ◽  
Skin Lightening

Kojic acid functions as an antioxidant in cosmetic products. Kojic acid was not a toxicant in acute, chronic, reproductive, and genotoxicity studies. While some animal data suggested tumor promotion and weak carcinogenicity, kojic acid is slowly absorbed into the circulation from human skin and likely would not reach the threshold at which these effects were seen. The available human sensitization data supported the safety of kojic acid at a use concentration of 2% in leave-on cosmetics. Kojic acid depigmented black guinea pig skin at a concentration of 4%, but this effect was not seen at 1%. The Cosmetic Ingredient Review (CIR) Expert Panel concluded that the 2 end points of concern, dermal sensitization and skin lightening, would not be seen at use concentrations below 1%; therefore, this ingredient is safe for use in cosmetic products up to that level.

2 Final Report on the Safety Assessment of Dilauryl Thiodipropionate

1992 ◽  
Vol 11 (1) ◽  
pp. 25-41 ◽  
Keyword(s):  
Guinea Pig ◽  
Safety Assessment ◽  
Lauryl Alcohol ◽  
Final Report ◽  
Cosmetic Products ◽  
Dermal Toxicity ◽  
Safety Test ◽  
Human Volunteers ◽  
Test Concentration ◽  
Rats And Mice

Dilauryl Thiodipropionate (DLTDP) is the diester of lauryl alcohol and 3,3′-thiodipro-pionic acid which is used as an antioxidant and sequestering agent in cosmetics at concentrations up to 1%. When administered orally to rats and mice, DLTDP was slightly toxic and was relatively nontoxic in subchronic oral studies with rats. No irritation was produced by a formulation containing 0.05% DLTDP when tested at 0.0025% on intact and abraded skin. DLTDP was nonmutagenic in four different assay systems. This cosmetic ingredient was not a teratogen or reproductive toxicant in oral studies in mice, rats, hamsters or rabbits. A formulation containing 0.05% DLTDP when tested at 0.05% was not a sensitizer in a guinea pig maximization test. DLTDP, at a concentration of 0.05% in a makeup foundation, was not an irritant, sensitizer, or phototoxin when tested on human volunteers. The maximum reported safety test concentration used in dermal toxicity of DLTDP was 0.05%. The report limits its safety conclusion by concluding that DLTDP is safe for use in cosmetic products at the maximum dermal tested concentration of 0.05%.

scholarly journals Final Report on the Safety Assessment of Glyceryl Stearate and Glyceryl Stearate/SE

1982 ◽  
Vol 1 (4) ◽  
pp. 169-192 ◽  
Keyword(s):  
Adverse Effects ◽  
Safety Assessment ◽  
Mouse Skin ◽  
Toxicity Tests ◽  
Final Report ◽  
Acute Oral Toxicity ◽  
Dermal Toxicity ◽  
Oral Toxicity ◽  
Patch Tests ◽  
Cosmetic Formulations

Glyceryl Stearate and Glyceryl Stearate/SE are the esterification products of glycerine and stearic acid, and are used in cosmetic formulations as emollients, emulsifiers, and stabilizers. In acute oral toxicity studies in rats, both ingredients were slightly toxic. Glyceryl Stearate in the diet of rats for three consecutive generations had no adverse effects. Five percent Glyceryl Stearate did not promote the carcinogenicity of DMBA in mouse skin. In subchronic and chronic dermal toxicity tests, Glyceryl Stearate was nontoxic to rabbits but did cause moderate irritation. Primary eye irritation studies, at concentrations up to 100%, were mildly irritating or nonirritating to rabbits. Single and Repeated Insult Patch Tests showed both ingredients to be nonsensitizing and nonirritating. Products containing 2% Glyceryl Stearate were nonphototoxic and nonphotoallergenic. On the basis of the available data, it is concluded that Glyceryl Stearate and Glyceryl Stearate/SE are safe for topical application to humans in the present practices of use and concentration.

2 Final Report on the Safety Assessment of Propyl Gallate

1985 ◽  
Vol 4 (3) ◽  
pp. 23-64 ◽  
Keyword(s):  
Human Skin ◽  
Propyl Gallate ◽  
Guinea Pigs ◽  
Safety Assessment ◽  
Final Report ◽  
Cosmetic Products ◽  
Oral Toxicity ◽  
Toxicity Studies ◽  
Animal Toxicity

Propyl Gallate acid is used as an antioxidant in cosmetic products at concentrations normally less than 0.1 percent. Propyl Gallate is absorbed when ingested, methylated, conjugated, and excreted in the urine. Acute animal toxicity studies indicate that Propyl Gallate is slightly toxic when ingested and practically nontoxic when applied to the skin. Numerous chronic oral toxicity studies indicate that Propyl Gallate at concentrations up to 5 percent is practically nontoxic to rats, mice, dogs, and guinea pigs. Propyl Gallate is nonirritating to human skin at concentrations up to 10 percent; however, it is sensitizing at this and higher concentrations. Propyl Gallate was nonphototoxic. It is concluded that Propyl Gallate is safe as a cosmetic ingredient at concentrations not exceeding 1 percent.

Final Report on the Safety Assessment of Quaternium-22

1995 ◽  
Vol 14 (6) ◽  
pp. 485-497
Keyword(s):  
Safety Assessment ◽  
Adverse Reactions ◽  
Toxicity Study ◽  
Final Report ◽  
Test Substance ◽  
Cosmetic Products ◽  
Dermal Toxicity ◽  
Oral Toxicity ◽  
Ethylene Chlorohydrin ◽  
Ocular Exposure

The quaternary ammonium salt Quaternium-22 is used as a film former, hair conditioning agent, and antistatic agent in a wide variety of cosmetic products. This ingredient has reportedly also been used as an emollient and skin conditioner. It is supplied in water with 60% solids (Quaternium-22). Impurities include 3-dimethylaminopropylamine (DMAPA) at concentrations up to 2.45%, and ethylene chlorohydrin (ECH) up to 0.097%. The maximum concentration of Quaternium-22 in formulations is 5.0%. An acute oral toxicity study in rats using 6% Quaternium-22 failed to kill any of the animals. Exposure to 0.5% Quaternium-22 was a slight irritant in a 28-day dermal toxicity study in rabbits; no other adverse reactions related to the test substance were found. Ocular exposure to 8.5% Quaternium-22 produced minimal conjunctival irritation, but 6% did not. Intracutaneous injections of 6% Quaternium-22 did not produce irritation or sensitization in Guinea pigs. No evidence of mutagenesis was seen in the Ames test. Clinical data revealed no irritation or sensitization, nor was there any evidence of photosensitization. While there was some concern over the toxicity of the DMAPA and ECH impurities, the absence of any toxicologic or mutagenic findings on exposure to material containing these impurities suggested there were no adverse effects associated with either the ingredient or any impurities. In order that exposure to these impurities be kept low, however, it was recommended that the concentration of this ingredient in cosmetic products should be limited so that the concentration of DMAPA not exceed 0.2% and that of ECH not exceed 0.008%-this is consistent with the expected use of Quaternium-22 at ≥ 5% solids. Accordingly, it was concluded that the cosmetic ingredient Quaternium-22 is safe in the present practices of use.

Final Report of the Safety Assessment of Polyamino Sugar Condensate

1982 ◽  
Vol 1 (4) ◽  
pp. 25-32 ◽  
Keyword(s):  
Amino Acids ◽  
Safety Assessment ◽  
Condensation Reaction ◽  
Skin Irritation ◽  
Safety Data ◽  
Final Report ◽  
Acute Oral Toxicity ◽  
Oral Toxicity ◽  
Animal Data ◽  
Mild Irritant

Polyamino Sugar Condensate (PSC) is the product of a condensation reaction between amino acids and sugars. It appears in over 100 cosmetic preparations at concentrations up to 1%. PSC has an acute oral toxicity greater than 5 g/kg in rats. In tests on rabbits, undiluted PSC was not a primary irritant and produced only mild irritation in some animals. Subacute skin irritation was not observed in rabbits when PSC (undiluted) was applied. Human safety data indicate that PSC is nonsensitizing and, at worst, a mild irritant. PSC is also nonphototoxic. On the basis of the available animal data and limited human experience, it is concluded that Polyamino Sugar Condensate is safe for topical application to humans.

4 Final Report on the Safety Assessment of Isopropyl Linoleate

1992 ◽  
Vol 11 (1) ◽  
pp. 51-56 ◽  
Keyword(s):  
Linoleic Acid ◽  
Test Data ◽  
Safety Assessment ◽  
Isopropyl Alcohol ◽  
Corn Oil ◽  
Final Report ◽  
Acute Oral Toxicity ◽  
Cosmetic Products ◽  
Oral Toxicity ◽  
Safety Test

Isopropyl Linoleate is the ester of isopropyl alcohol and linoleic acid. In cosmetics, it is used as a skin conditioning agent and emollient at concentrations ranging from 0.1 % to 10.0%. In an acute oral toxicity study, none of the albino rabbits that received doses of 10.0% Isopropyl Linoleate in corn oil died. Isopropyl Linoleate (undiluted and 10.0% suspension) were classified as slight ocular irritants. Undiluted Isopropyl Linoleate was classified as a slight skin irritant. The report concludes that the safety of use of Isopropyl Linoleate has not been documented and substantiated, and that it is not possible to conclude that the ingredient is safe for use in cosmetic products. The report details the type of safety test data that is needed to substantiate the safety of use of Isopropyl Linoleate in cosmetic products.

scholarly journals 2: Final Report on the Safety Assessment of Glyceryl Ricinoleate

1988 ◽  
Vol 7 (6) ◽  
pp. 721-739 ◽  
Keyword(s):  
Ricinoleic Acid ◽  
Castor Oil ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Ultraviolet Spectrum ◽  
Toxicity Tests ◽  
Final Report ◽  
Dermal Toxicity ◽  
Oral Toxicity ◽  
Patch Tests

Glyceryl Ricinoleate is the monoester of glycerol and ricinoleic acid. Castor oil contains 87–90% Glycerol Ricinoleate. Ricinoleic acid is metabolized by both β-oxidation and α-oxidation. Acute oral toxicity tests in mice indicated that Glyceryl Ricinoleate has an LD50 greater than 25.0 ml/kg and is, at most, mildly irritating to unrinsed rabbit eyes. This ingredient was not a primary skin irritant. Castor oil was nonmutagenic by the Ames test. Ricinoleic acid was not a carcinogen when tested in mice. In human single-insult occlusive patch tests, no indication of skin irritation potential was observed in the two products containing 5.6% Glyceryl Ricinoleate. The available data on Glyceryl Ricinoleate were insufficient to determine whether this ingredient, under each relevant condition of use, was either safe or not safe. The types of data required before a decision can be made include: (1) 28 day chronic dermal toxicity in guinea pigs, and (2) clinical sensitization and photosensitization studies (or an appropriate ultraviolet spectrum instead of the photosensitization data).

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